UPC decision highlights practical considerations for patent injunction proceedings

Sarah Taylor, patent expert at Pinsent Masons, was commenting on a recent decision (44-page / 1MB PDF) in which the UPC's Milan Local Division (LD) granted a UPC-wide preliminary injunction (PI) in favour of Abbott Diabetes Care in a patent infringement dispute concerning continuous glucose monitoring (CGM) devices used to monitor blood glucose levels in diabetic patients.

The court emphasised a number of factors that may be relevant when deciding whether to admit such arguments including whether the opposing party has had a meaningful opportunity to respond; whether any new factual material or evidence has been introduced; and the procedural realities of provisional measures proceedings, where parties are operating under significant time pressures.

“The decision demonstrates that, although the UPC enforces a strict, front-loading principle, it will take a pragmatic approach to late-filed arguments, particularly in proceedings for provisional measures, particularly PIs, where deadlines are tight,” Taylor said.

The dispute centred on Abbott’s European patent, which related to a glucose-sensor insertion assembly used in devices designed to monitor blood glucose levels in diabetic patients. Abbott alleged that five respondents intended to market an allegedly infringing product, the GS3-R System, within UPC territories.

Although the product had not yet been launched in UPC member states, Abbott argued that the respondents had already undertaken the regulatory and commercial preparations necessary for launch, giving rise to an imminent threat of infringement.

The court ultimately found that it was more likely than not that Abbott’s patent was valid and that the GS3-R System infringed the patent. On that basis, it granted a UPC-wide PI.

The UPC has a stringent approach to the admissibility of late filed arguments and evidence, enforcing a ‘front-loaded’ procedure to preserve the speed and efficiency of its decisions. Here, however, a significant procedural issue arose after the respondents advanced certain claim interpretation and non-infringement arguments for the first time in their final written submissions.

The court allowed those arguments to be considered, citing several factors.

First, it noted that claim construction is a matter of law on which the court may act of its own motion. Had the arguments been excluded, the UPC Court of Appeal could in all likelihood have taken them into account anyway, meaning one level of jurisdiction on a substantive issue would have been lost.

Second, the LD opined that, in accordance with the adversarial principle and right of defence, it is “essential and indispensable” that the opposing party is always given the opportunity to be heard. In this scenario, the respondents introduced the argument one month before the oral hearing, relying on no new factual material or documents.

Third, the court found that significance must be attached to the applicant’s conduct. Here, Abbott merely objected to admissibility but did not request a short period in which to submit a written response and was given an adequate opportunity to address the issue at the oral hearing.

Finally, the court also considered the compressed timetable that typically applies in provisional measures proceedings. In such circumstances, there are considerable time pressures and parties are required to respond, and therefore formulate their arguments, within very short timeframes.

In its decision, the court warned against what it described as an “overly rigid application” of the front-loaded character of UPC proceedings in the context of applications for provisional measures. It concluded that excluding the arguments would have imposed a disproportionate restriction on the respondents’ rights of defence.

Taylor said: “The   decision provides guidance as to how a party wishing to object to such late filed evidence should proceed, it being prudent to accompany objections to late filed arguments with an alternative request for a written response to support any allegations of procedural prejudice.”

Although the court allowed the respondents’ late filed arguments to be admitted, it ultimately found in favour of Abbott and granted the UPC-wide PI.

The ruling also addresses the potential liability of EU authorised representatives under the EU’s Medical Devices Regulation (MDR).

In its decision, the Milan LD held that the role undertaken by Shanghai International Holding Corp GmbH, as the GS3-R System’s EU authorised representative, went beyond a purely formal function and made a “material and legally relevant contribution” to placing the allegedly infringing product on the EU market.  Relying on the UPC Court of Appeal’s earlier Philips v Belkin decision, the court held that liability for infringement under the UPC Agreement is not confined solely to parties carrying out infringing acts directly, but may extend to those who act as instigators, co-perpetrators or accessories.  As such, the LD that the authorised representative could itself be treated as an infringer.

Taylor said: “This contrasts with the decision of the Düsseldorf LD in Aesculap v Shanghai Bojin Medical Instrument Co. Although both divisions found the EU authorised representative may be liable for infringement due to the nature of their role, their reasoning differed.” 

In the Aesculap case, the court reasoned that, while the EU authorised representative performs an “indispensable role” in the lawful marketing of medical devices, it was liable for infringement but only as an intermediary.

“The differences may be down to a number of reasons,” Taylor said.

“These reasons likely include the different facts and evidence before the courts, and that the Düsseldorf LD ruling was a final merits decision, whereas the Milan LD determination was a provisional measures decision.  Further clarity will ultimately be required as to how the potential liability of an EU authorised representative, required by the Medical Device Regulation, will be considered,” she added.